隨著細(xì)胞治療相關(guān)研究的不斷推進(jìn)，部分細(xì)胞治療產(chǎn)品已經(jīng)應(yīng)用于臨床研究。然而，我國(guó)相應(yīng)的細(xì)胞治療監(jiān)管政策仍需進(jìn)一步完善，這有利于我國(guó)的細(xì)胞治療產(chǎn)業(yè)發(fā)展，同時(shí)保障患者利益。從不同類型的細(xì)胞治療出發(fā)，結(jié)合現(xiàn)有技術(shù)能力，就目前細(xì)胞治療可行的質(zhì)量控制和管理方法做出論述，以期起到拋磚引玉的作用，引導(dǎo)社會(huì)各方制定更為科學(xué)規(guī)范的管理措施。

With the efficacy proofs of immune cell therapy research, part of cell products have been applied in clinical practice. However, the companion management regulations in China still need to be further improved, which is beneficial to the development of cell therapy in China and guarantee of treatment for patients. Based on different types of cell therapy, this report discusses the quality control and management of cell therapy in regard to the techniques available. To cast a brick and attract jade, we provide suggestions for the scientific standardization of cell therapy.

R926

國(guó)家科技重大專項(xiàng)課題——重大新藥創(chuàng)制（2016ZX09101094）；北京市科委企業(yè)技術(shù)創(chuàng)新平臺(tái)建設(shè)（Z181100000518028）